Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
The main purpose of this study is to examine the treatment effects and the combined-therapy of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in the investigators trial to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 18, 2014
December 1, 2014
4 years
October 7, 2014
December 15, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
change of kinematic analyses
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), maximum shoulder and elbow cross-correlation and variables of gait pattern were collected.
within three days before and immediately after the intervention
change of Fugl-Meyer Assessment
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
within three days before and immediately after the intervention
Secondary Outcomes (4)
change of 10-Meter Walk Test (10MWT)
within three days before and immediately after the intervention
change of Wolf Motor Function Test
within three days before and immediately after the intervention
change of Functional Independence Measure
within three days before and immediately after the intervention
change of The Action Research Arm Test
within three days before and immediately after the intervention
Other Outcomes (6)
change of Medical Research Council scale
within three days before and immediately after the intervention
change of Functional Ambulation Categories
within three days before and immediately after the intervention
change of Modified Ashworth Scale
within three days before and immediately after the intervention
- +3 more other outcomes
Study Arms (6)
RAT-NMES
EXPERIMENTALThe combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.
RAT-MT
EXPERIMENTALThe combined treatment of robot-assisted therapy and mirror therapy.
Mirror therapy
ACTIVE COMPARATORPatients practice motion in a mirror box, and look into mirror while practicing.
Unilateral RAT
EXPERIMENTALUnilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.
Bilateral RAT
ACTIVE COMPARATORBilateral robot-assisted therapy provided by Bi-Manu-Track.
Conventional rehabilitation
ACTIVE COMPARATORConventional rehabilitation provided by therapist.
Interventions
This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive neuromuscular electrical stimulation (NMES) concurrently with RAT.
This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive mirror therapy instead of functional activities training after RAT.
This protocol includes mirror therapy and functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
This protocol includes warm-up, unilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The unilateral RAT session uses the robot-assisted arm trainer, InMotion Isokinetic Testing and Evaluation System.
This protocol includes warm-up, bilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The unilateral RAT session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RAT and MT groups.
Eligibility Criteria
You may qualify if:
- first-ever unilateral stroke with more than 3 months onset ;
- an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment;
- no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers);
- be able to follow study instructions and perform study tasks;and
- willing to provide written informed consent.
You may not qualify if:
- with neural or psychological medical problem that may influence the study;
- with severe joint pain;
- with upper limb fracture within 3 months;
- participation in any experimental rehabilitation or drug studies during the study period; and
- refusing to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cathay General Hospitallead
- National Taiwan Universitycollaborator
- Chang Gung Universitycollaborator
- Chang Gung Memorial Hospitalcollaborator
- Cheng-Hsin General Hospitalcollaborator
- Lo-Sheng Sanatoriumcollaborator
Study Sites (1)
Cathay General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Keh-Chung Lin, Dr.
National Taiwan University
- PRINCIPAL INVESTIGATOR
Chia-Yi Lee, MD
Cathay General Hospital
- PRINCIPAL INVESTIGATOR
Ming-wei Lee
Cathay General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
December 18, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
December 18, 2014
Record last verified: 2014-12